CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 145 enrolled
Drug / intervention
Active Laser +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01738737
NCT01738737N/ACompleted

Effect of Low-level Laser Therapy (904 nm) and Static Stretching in Patients With Knee Osteoarthritis: Randomised Controlled Trial.

University of Sao Paulo General Hospital·interventional·Posted Nov 30, 2012·Updated Dec 10, 2015

In Brief

A clinical study evaluating Active Laser, Stretching exercises, and 1 other intervention for Osteoarthritis, Knee. Completed, enrolled 145 participants across 1 site.

Detailed Summary

Osteoarthritis (OA) is a highly prevalent and disabling disease. It is estimated that by 2030 the prevalence of symptomatic OA could reach 30% of the population above 60 years. It is associated with significant morbidity being one of the most common causes of joint pain, functional disability and compromised quality of life. This randomised controlled trial will investigate the effect of low-level laser therapy (LLLT) and static stretching exercises, as monotherapy and in combination, on pain, quality of life, function, mobility, knee range of motion (KROM) and hamstring length in participants with knee OA. This study will involve 145 people aged 50-75 years with symptomatic radiographic knee OA and will consist of two types of treatments: Low-level laser therapy (LLLT) and stretching exercises. The patients will be randomly allocated to five study groups LLLT active+Stretch, LLLT placebo+Stretch, Stretch, LLLT and Control (with n=29 each). Treatment frequency will be three sessions/week for all active groups. LLLT will involve the use of a Galium-Arsenide laser (904nm, 40 milliwatts, 3 Joules/point, 27 Joules/knee) over 24 sessions for the monotherapy group and 9 sessions for the LLLT+Stretch groups. Stretching will consist of seven exercises completed over 24 sessions. The control group will receive a booklet. The primary outcome is pain measured by Visual Analogue Scale. Secondary outcomes included quality of life assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC), function by Lequesne Algofunctional Index, mobility by Timed Up and Go Test (TUG), KROM by goniometry of knee flexion and hamstring shortening by popliteal angle. The statistical method will follow the principles of per-protocol analysis.

Study Details

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2012
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.6 years ago

Interventions

Active Laserdevice

18 points of application of active laser in the knee (frontal faces, lateral and medial)

Stretching exercisesother

7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions

placebo laser therapydevice

18 points of application of placebo laser in the knee (frontal faces, lateral and medial)